Identity
- Trade Name
- Universal EUDAMEDUniversal Abutment FDA UDI
- Generic Name
- Dental implant suprastructure, permanent, preformed FDA UDI
- Device Name
- Dental Abutment EUDAMEDUniversal Abutment UA5 SP 0° - 2.0mm Post FDA UDI
- Model / Reference
- 260-150-710 EUDAMEDFDA UDI
- Description
- Universal Abutment UA5 SP 0° - 2.0mm Post FDA UDI
Identifiers
- Catalog Number
- 260-150-710 FDA UDI
- Primary DI / UDI-DI
- 00813110021144 EUDAMEDFDA UDI
- Basic UDI-DI
- 081311002TAbut5L EUDAMEDB-00813110021144 EUDAMED
- 510(k) Number
- K853788 FDA UDI
- FDA Product Code
- DZE FDA UDI
- EMDN Code
- P010299 ODONTOLOGICAL PROSTHESES - OTHER EUDAMED
- GMDN Term
- Dental implant suprastructure, permanent, preformed FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3640 FDA UDI
- Market of Registration
- Ireland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
Yes
Reusable
No
Contains Latex
No
Reprocessed
No
Sutures
Yes
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Dental implant suprastructure, permanent, preformed
Universal by Bicon, Llc — Class IIb — MDD, MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDD
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 081311002TAbut5L | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | 081311002TAbut5L | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Bicon, LLC
- EUDAMED SRN
- US-MF-000002782
- Authorised Representative
- Bicon Europe Ltd IE-AR-000002497
Sources (3)
- EUDAMED 377e26b0-b13a-4cdc-8c7b-c01f4b1daa1a 61 fields · synced Jun 18, 2026
- EUDAMED 80b9b027-6f11-4a1b-9556-7f18f4469eec 61 fields · synced May 19, 2026
- FDA UDI 3b942d87-0882-4166-be8a-5fcedf105397 36 fields · synced May 30, 2026